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Here, we outline the processes and best practices applied at a GMP facility to optimize the production of working virus seed stocks and master virus seed stocks. Learn about the relevant regulatory and testing requirements as well as key factors for ensuring the successful manufacture of virus banks.
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Explore the Cell & Gene therapy (CGT) products now within scope of the ICH Q5A guidance, descriptions of where alternative technologies can replace traditional testing strategies, the additional viral clearance studies some vector products are expected to complete, and how these changes will influence the viral safety testing strategies for future CGT products.
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The use of Next Generation Sequencing (NGS) in the biosafety testing space has grown dramatically over the past decade with the advent of advanced instrumentation. Examine a NGS adventitious agent testing (AAT) method for cell line characterization, representative results from a HEK293 master cell bank, and more.
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Review the key manufacturing principles of lentiviral (LV) vectors for clinical trials or commercial use, regulatory considerations specific to the testing requirements of LV vectors, and testing strategies for LV vectors with a particular focus on the replication-competent virus assay and infectious titer assay.
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